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NCT ID: NCT02118896 Completed - Clinical trials for Kidney Transplantation

Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant

Start date: February 24, 2003
Phase: Phase 3
Study type: Interventional

The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

NCT ID: NCT02115477 Completed - Hysterectomy Clinical Trials

Lymphedema After Primary Surgery for Endometrial Cancer

LASEC
Start date: April 17, 2014
Phase:
Study type: Observational

The purposes of this study are - to determine the prevalence, size and impact on quality of life of lymphedema of the lower extremities after primary radical surgery with hysterectomy +/- pelvic - and paraaortic lymphadenectomy in women with endometrial uterine carcinoma FIGO (International Federation of Gynecology and Obstetrics) stage 1 and 2 - to analyze risk factors for development of lymphedema in this specific group of patients. Our hypotheses are that women who have lymphadenectomy more often suffer from lymphedema, subjectively and objectively, and have an impaired quality of life. This is a Swedish multicenter study carried out in 17 departments of Obstetrics and Gynecology and in 3 departments of Oncology. All participants are treated according to the Swedish National Guidelines for Endometrial Cancer. 130 women with endometrial cancer who have a hysterectomy with lymphadenectomy (high-risk endometrial carcinomas) and 130 women with endometrial cancer who have a hysterectomy without lymphadenectomy (low-risk endometrial carcinomas) are prospectively enrolled in the study. The participants are examined preoperatively and on 3 occasions postoperatively, i.e. 4-6 weeks , 6 months and 12 months postoperatively. Determination of occurrence of lymphedema of the lower extremities are determined objectively by 1) a standardized clinical evaluation according to Bruna et al.[1] and 2) determining the leg volume according to the cone model by Sitzia [2] by systematically measuring of leg circumferences. In addition, occurrence of lymphedema is measured subjectively by the participants. On the same four occasions as the leg circumference measurements are conducted the patients complete two generic health related quality of life forms (the EuroQol EQ-5D and the Short-Form 36 SF-36) and the condition specific quality of life form for limb lymphedema (LYMQOL). Demographic and clinical data are systematically collected until one year postoperatively including occurrence of complications and given adjuvant oncological therapy such as chemo- and radiation therapy. On each occasion of clinical control a vaginal ultrasound examination is carried out in order to register pelvic and abdominal lymphocele formation or lymphatic fluid effusion intraabdominally.

NCT ID: NCT02114593 Completed - Mental Illness Clinical Trials

Ladnaan - an Evaluation of a Parent Support Program for Somali Parents

Start date: June 2014
Phase: N/A
Study type: Interventional

The aim of this project is to evaluate the effectiveness of a culturally adapted parenting support program for Somali parents living in Sweden on children's and parent´s mental health. In recent years the Somali population in Sweden has increased and is currently one of the largest groups among ethnic minorities. Most of the Somali people have arrived as refugees and have experienced war, trauma and conflict. Research shows that migration to a new social context/society is challenging for a family and may together with previous experiences of war, separation, create stress and mental illness. This leads to consequences such as family violence, child abuse, relational problems, drug problems and school problems for children. There is a vast knowledge on the association between parents' mental health, positive parent-child relationship and children's health and well-being. Previous studies have shown that parenting programs aimed to support parent-child relationship and/or improve parental skills have positive effects on parental mental health and on children's behavior. Most municipalities in Sweden offer their residents a structured parenting program, but these programs do not reach those of ethnic minorities. Studies show that parenting programs mainly target parents who can speak Swedish fluently and that the parenting programs are not yet culturally adapted.

NCT ID: NCT02113618 Completed - Clinical trials for Alcohol Use Disorders

Effect of Cognitive Training on Alcohol Use Outcomes

COGALC
Start date: October 2013
Phase: N/A
Study type: Interventional

To purpose of the present study is to investigate the feasibility and efficacy of a computerized working memory training in improving cognitive functioning and alcohol use outcomes, in individuals with alcohol use disorders.

NCT ID: NCT02113605 Completed - Clinical trials for Functional Dyspepsia

Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders

CBT
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.

NCT ID: NCT02113332 Completed - Clinical trials for Type 2 Diabetes Mellitus

Addition of Liraglutide to Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Liraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight. However, to date there are no clinical trials of liraglutide added to insulin therapy, a population of patients generally having worse glycaemic control and weight gain. In clinical guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic option for type 2 diabetic patients. The primary study aim is to evaluate whether the addition of liraglutide, compared to placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is defined as treatment with any basal insulin combined with separate meal time insulin injections before the main meals, i.e. an insulin regimen with premixed insulin is not considered as MDI. The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.

NCT ID: NCT02112383 Completed - Procrastination Clinical Trials

Group Versus Internet-based Cognitive Behavior Therapy for Procrastination

Start date: September 2014
Phase: N/A
Study type: Interventional

Procrastination is defined as a voluntarily delay of an intended course of action despite expecting to be worse-off for the delay, and is considered a persistent behavior pattern that can result in major psychological suffering. About one-fifth of the adult population and half of the student population are presumed having substantial difficulties due to recurrent procrastination in their everyday life. However, chronic and severe procrastinators seldom receive adequate care due to preconceptions and the lack of understanding regarding procrastination and the treatment interventions that are assumed beneficial. Cognitive behavior therapy is often deemed treatment of choice, although the evidence supporting its use is scarce, and only one randomized controlled trial has been performed. The primary aim of the current study is therefore to test the efficacy of cognitive behavior therapy delivered as either a group intervention or via the Internet. Participants will consist of students recruited through the Student Health Centre at Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants divided into two conditions will be employed; a ten week Internet-based cognitive behavior therapy intervention, and an eight week group intervention based on cognitive behavior therapy. The current study is believed to result in two important findings. First, different interventions inherent in cognitive behavior therapy are assumed to be helpful for people suffering from problems caused by procrastination. Second, both a group intervention and an Internet-based cognitive behavior therapy intervention are presumed suitable for administering treatment for procrastination, which is considered highly important as the availability of adequate care is limited, particularly among students. The current study will increase the knowledge regarding the efficacy of different treatments of procrastination, as well as enhance the overall comprehension of the difficulties related to dilatory behavior.

NCT ID: NCT02111577 Completed - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

VIABLE
Start date: May 26, 2014
Phase: Phase 3
Study type: Interventional

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

NCT ID: NCT02108158 Completed - Clinical trials for Glabellar Frown Lines

A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines

Start date: April 2014
Phase: Phase 4
Study type: Interventional

A randomized, evaluator-blinded, comparative, study to evaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure, in the glabellar lines.

NCT ID: NCT02106546 Completed - Clinical trials for Squamous Non-Small Cell Lung Cancer

Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Start date: April 10, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).